MAUDE Adverse Event Report: PENUMBRA, INC. NEURON 6F 070 DELIVERY CATHETER; DQY

Catalog Number	PND6F070956M
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for return.A follow up mdr will be submitted upon completion of the device investigation.
Event or Problem Description
During preparation for a medical procedure, the technologist noticed that the tip of the neuron 6f 070 delivery catheter (neuron 070) came off upon removal from the packaging.The broken neuron 070 was found prior to use and therefore, was not used for the procedure.The procedure was completed using a new neuron 070.
Additional Manufacturer Narrative
Please note that the device in complaint was expected to be returned; however, additional information received by the penumbra sales representative indicated that the device was misplaced by the hospital and is no longer available for return.Therefore, without the return of the device, the root cause of the problem cannot be determined.The manufacturing records for this lot were reviewed and did not reveal any outstanding discrepancies, design, or quality concerns.The device was misplaced by the hospital.

• Brand Name: NEURON 6F 070 DELIVERY CATHETER
• Common Device Name: DQY
• Manufacturer (Section D): PENUMBRA, INC.; one penumbra place; alameda CA 94502
• MDR Report Key: 5895194
• Report Number: 3005168196-2016-01209
• Device Sequence Number: 723817
• Product Code: DQY
• UDI-Device Identifier: 00814548010076
• UDI-Public: 00814548010076
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K082290
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Radiologic Technologist
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: PND6F070956M
• Device Lot Number: F68167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2016
• Supplement Report FDA Received Date: 04/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1